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National Coverage Analysis (NCA) Tracking Sheet for Ocular Photodynamic Therapy with Verteporfin for Macular Degeneration (CAG-00066R3)

Ocular Photodynamic Therapy (OPT) is a treatment for age-related macular degeneration (AMD), a common eye disease among the elderly. AMD is the leading cause of blindness in adults over the age of 50. OPT involves the infusion of an intravenous (IV) photosensitizing drug called verteporfin followed by exposure to a laser. The laser activates verteporfin, which selectively targets and treats the pathologic ocular tissue. On April 13, 2000, the Food and Drug Administration (FDA) approved verteporfin for treating AMD in patients with predominantly classic subfoveal choroidal neovascularization (CNV) as determined by a fluorescein angiogram. The laser devices for use in OPT have also received FDA approval.

On November 8, 2000, The Health Care Financing Administration (HCFA) announced its decision to cover OPT with verteporfin for AMD patients with predominantly classic CNV lesions (where the area of classic CNV occupies >50% of the area of the entire lesion) as determined by a fluorescein angiogram. (CNV lesions are made up of classic and/or occult components). This policy was effective July 1, 2001.

Subsequently, HCFA became aware of evidence not previously considered addressing the therapy's effectiveness in AMD patients with subfoveal occult CNV with no classic CNV (i.e. patients with 0% classic CNV). HCFA reviewed the new evidence to determine if Medicare's national coverage decision on OPT with verteporfin should include this indication.

On October 17, 2001 The Centers for Medicare and Medicaid Services (CMS), formerly HCFA, announced its intent to cover OPT with verteporfin for AMD patients with occult and no classic subfoveal CNV as determined by a fluorescein angiogram. After posting this Decision Memorandum, CMS discovered new issues concerning the data from the clinical trial upon which it based its analysis.

On October 29, 2001, in order to further examine the clinical trial data, CMS internally generated a request for reconsideration of this indication. CMS did not implement the October 17, 2001 memorandum pending completion of the reconsideration.

On March 28, 2002, CMS announced its intent to reaffirm the current national noncoverage policy for OPT with verteporfin for AMD patients with occult and no classic subfoveal choroidal neovascularization (CNV) as determined by a fluorescein angiogram.

On May 27, 2003, as part of an agreement to settle pending litigation, CMS agreed to convene a Medicare Coverage Advisory Committee (MCAC) meeting to evaluate scientific evidence and make non-binding recommendations to CMS regarding verteporfin for AMD patients with occult and no classic subfoveal CNV.

Drugs and Biologicals
Physicians' Services
Requestor Name(s)Internally generated request
Formal Request Accepted and Review Initiated07/25/2003
Expected NCA Completion Date01/31/2004
Public Comment Period08/25/2003 - N/A
Decision Memo Released01/28/2004
Lead Analyst(s)
Lead Medical Officer(s)
  • Marc Stone, MD

July 25, 2003

CMS opens a reconsideration of the current national noncoverage policy for OPT with verteporfin for AMD patients with occult and no classic subfoveal choroidal neovascularization (CNV) as determined by a fluorescein angiogram.

The Medicare Coverage Advisory Committee (MCAC) will convene September 9, 2003 to review the issue of OPT with verteporfin for age-related macular degeneration.

October 23, 2003

Minutes and Transcript of the September 9, 2003, MCAC meeting were received on October 22, 2003. Accordingly, the new due date for the NCD staff review is December 22, 2003.

December 18, 2003

On December 4, 2003, an investigator in the TAP and VIP trials submitted a large volume of information to CMS. In accordance with our usual process, CMS requires additional time to analyze this new information. As a result, the new due date for the decision is January 31, 2004.

January 28, 2004

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